CompletedPhase 2

Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

Denmark100 participantsStarted 2014-04

Plain-language summary

The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft tissue infections (NSTI).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Necrotizing soft tissue infection (NSTI) based on surgical findings * Age \>18 years * Admitted to or planned to be admitted to the ICU at Rigshospitalet (RH) Exclusion Criteria: * \>48 hour from the primary diagnosis to arrival at RH * More than one dose of IVIG given within current admission * Known hypersensitivity to IVIG * Hyperprolinaemia (obtained from hospital notes) * Pregnancy or breast feeding

What they're measuring

Physical Component Summary Score (PCS) of Short-Form 36 (SF-36)

Timeframe: Six months after randomisation

Trial details

NCT IDNCT02111161

SponsorAnders Perner

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Necrotizing Soft Tissue Infection trials